Kornimate/medical-research-clean huggingface dataset:
abatacept reversing subclinical inflammation as measured by mri in acpa positive arthralgia

Conditions: Arthralgia; Arthritis

Summary: this is a randomised double-blinded placebo-controlled multi centre study in 98 patients with acpa positive arthralgia. the study is composed of 2 arms with a 1:1 randomisation at baseline: treatment phase will be 6 months. group 1: abatacept s.c. 125 mg weekly for 6 months vs. group 2: placebo s.c. for 6 months. after 6 months both groups will run into the follow up period for another 12 months up to month 18. patients developing arthritis will be treated according to local guidelines.


Eligibility criteria:
inclusion criteria: * females and males aged ≥ 18 years at time of consent * acpa (with or without rf) * joint pain (hand, feet, knee, shoulder or elbow) present for at least 6 weeks prior to inclusion or in past history * presence of synovitis (synovialitis or tenosynovitis) or osteitis in mri of the dominant hand at baseline * women of childbearing potential or men capable of fathering children must be using effective contraception during treatment with abatacept and up to 14 weeks after the last dose of abatacept treatment. * must understand and voluntarily sign an informed consent form including written consent for data protection * must be able to adhere to the study visit schedule and other protocol requirements exclusion criteria: * presence of arthritis in hand, feet, knee, shoulder or elbow joints defined as swelling * current treatment with glucocorticoids conventional or biologic dmards * previous treatment with abatacept * investigational study drug within 4 weeks (or 5 half lives, whichever is longer) prior to randomization * any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * any other autoimmune or inflammatory disease such as sle, pss, mctd, spa, behcet disease, vasculitis or autoimmune hepatitis. * any malignancy in the last 5 years * chronic infection such as latent tb (tb not adequately treated according to guidelines) or hepatitis b or c infection * immunocompromised or hiv-positive patients * uncontrolled severe concomitant disease * patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 abs. 4 and § 41 abs. 2 and abs. 3 amg). * pregnant or lactating females * patients who possibly are dependent on the principal investigator or investigator (e.g. family members).

Keywords: abatacept
a comparison of the effect of 1.5 versus 3% nacl on brain relaxation and microcirculation

Conditions: Brain Tumors

Summary: hyperosmotic solutions of 1.5% and 3% nacl are equally effective for brain relaxation and microcirculation during brain surgery. the effect of 1.5% nacl on postoperative natremia and natriuresis is less pronounced.

all the patients meeting the study criteria will be randomized into two groups. after standardized induction to general anesthesia all patients will be given the infusion of hyperosmotic nacl 5 ml/kg/bw during 30 min, group a 1.5% nacl, group b 3% nacl. corticosteroids will be administered as usually. after dura opening the brain relaxation score will be assessed by surgeon (1 = completely relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain), and the first measurement of the brain microcirculation provided by use of sdf probe in the area of the healthy brain, and of perifocal oedema. both sites of investigation will be marked for the second measurement, which will be done after the end of tumor resection. laboratory examinations: natremia preoperatively, natremia and osmolarity peroperatively 1 hour after nacl infusion and at the end of surgery. concentration of natrium will be examined in csf after dura opening. anesthesia management will be according to the standardised protocol, the patients will be awaken and extubated after the end of the procedure at the operating theatre.

Eligibility criteria:
inclusion criteria: * peripheral supratentorial brain tumors or metastasis * indication for osmotherapy * asa status i-iii exclusion criteria: * reoperation * osmotherapy prior to surgery * preoperative natremia less than 135 mmol/l and more than 140 mmol/l * gcs less than 14 * obstructive hydrocephalus

Keywords: brain tumors microcirculation osmotherapy hypertonic nacl natremia
study to assess the effect of pf-04531083 on heat pain in healthy volunteers with ultraviolet light sensitized skin

Conditions: Healthy

Summary: pf-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. this study is designed to see if this is also true in man.


Eligibility criteria:
inclusion criteria: * healthy volunteers. * body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg. exclusion criteria: * subjects that have any condition possibly affecting drug absorption (eg, gastrectomy). * treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. * subjects with inadequate cardiac function (ecg demonstrating prolonged qtc interval at screening). * subjects with inadequate or excessive sensitivity to uvb light.

Keywords: healthy volunteers cross-over randomized placebo and active controlled heat pain uvb-induced pain model
evaluation of feno during and following acute copd exacerbation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this research study is to determine whether exhaled nitric oxide (feno) goes up during an acute exacerbation of chronic obstructive pulmonary disease (aecopd) and whether the level of exhaled nitric oxide returns to normal in the weeks after an exacerbation.

the purpose of this research study is to determine whether exhaled nitric oxide (feno) goes up during an acute exacerbation of copd and whether the level of exhaled nitric oxide returns to normal in the weeks after an exacerbation. feno is measured with a medical device called the niox mino®. the niox mino® device has been cleared by the food and drug administration (fda) for use in children and adults age 7 and older to measure fractional exhaled nitric oxide (feno) in human breath.this information will be useful for determining whether feno may help predict the development of a copd exacerbation and/or be useful for identifying patients who will have a beneficial therapeutic response to inhaled or systemic corticosteroids during a copd exacerbation.

Eligibility criteria:
inclusion criteria: * age: 40 years and above, inclusive * sex: males and females * smoking history: ≥20 pack years. * copd defined as an fev1/ fvc or fev1/svc ratio \<70% predicted. * aecopd defined as a clinically significant worsening of copd symptoms requiring treatment with antibiotics and/or systemic steroids and/or hospitalization for same. exclusion criteria: * use of systemic corticosteroids for more than 48 hours prior to visit 1. * aecopd requiring mechanical ventilation * study participation outside of this protocol: patients currently enrolled in studies of investigational or non-investigational drugs or medical devices and/or who participated in these studies within 30 days prior to this study are excluded.

Keywords: copd chronic obstructive pulmonary disease exhaled nitric oxide niox mino acute copd exacerbation
concurrent chemoradiotherapy with weekly cisplatin versus concurrent chemoradiotherapy with weekly cisplatin and paclitaxel in locally advanced carcinoma cervix

Conditions: Carcinoma Cervix

Summary: the purpose of this study is to check whether addition of paclitaxel to cisplatin and radiation therapy will improve the outcome in locally advanced carcinoma cervix.

carcinoma cervix is the 2nd most common malignancy among females and about 86% of this burden occurs in developing countries. india accounts for 27% of world cervical cancer burden; and most of them are of locally advanced stage ie stage iia to iva. significant development in radiation techniques and addition of cisplatin based chemotherapy to radiation schedule has led to improved survival but still it is far from satisfactory with 20 to 25% patients failing locally while 10 to 20% patients fail at distant sites. novel techniques are required to improve this dismal rate. thus investigators intended to use combination chemotherapy with paclitaxel and cisplatin, considering that paclitaxel is a taxane which has shown good efficacy in other solid tumors such as ovary, lung and breast; it has also shown radiosensitizing effect in cervical cancer cell lines and it has also been shown to be effective in phase iii trials with cisplatin in metastatic and recurrent carcinoma cervix.

Eligibility criteria:
inclusion criteria: * histologically proven carcinoma cervix * age 18 years to 65 years * stage iia, iib, iiia \& iiib according to figo 2009 exclusion criteria: * age \> 65 years and \< 18 years * stage ia, ib, iva \& ivb * histology other than squamous cell, adenocarcinoma or adenosquamous carcinoma * history of prior pelvic surgery for cancer, prior pelvic radiotherapy or prior chemotherapy. * deranged renal function test and liver function test * kps \>= 60 * distant metastasis
use of biopsies of abdominal subcutaneous fat to study the role of the activation of endocannabinoid 1 receptors (cb1r) on adipocyte glucolipid metabolism

Conditions: Hernia Surgery

Summary: obesity is associated with hyperactivation of the endocannabinoid system, and its inhibition by the administration of cb1 receptor (cb1r) antagonists, leads to a decrease in food intake, weight loss and an improvement in metabolic parameters. even though the reduction in food intake following central cb1r inactivation seems to be the principal cause of weight loss and the improvement in metabolic parameters, several studies in animals and humans have indicated that peripheral cb1r could also be implicated in the regulation of glucolipid metabolism. as a result, it has been suggested that the long-term beneficial effects of inactivation of the endocannabinoid system are due to both central effects on food intake and peripheral effects involving adipose tissue, the liver, skeletal muscle and the pancreas. it appears essential to determine the role of cb1r located in peripheral tissues and in particular in adipose tissue, which plays an active role in maintaining glucolipid homeostasis. the experiments conducted in this project consist in studying in biopsies of abdominal subcutaneous fat whether activation of adipocyte cb1r modifies adipocyte metabolism by determining the mechanisms. the investigators hypothesize that activation of cb1r in adipose tissue will lead to the stimulation of lipolysis dependent on the alteration of the insulin signal, and therefore that inactivation of the endocannabinoid system by blocking peripheral cb1r could constitute a therapeutic approach to improve obesity-related insulin resistance and dyslipidaemia.


Eligibility criteria:
healthy subjects inclusion criteria: * men aged 18 to 70 years * persons who have provided oral consent * persons undergoing surgery for hernia exclusion criteria: * persons without health insurance cover * bmi \> 30 * diabetes * associated diseases: cancer, chronic inflammatory diseases * adults under guardianship obese subjects inclusion criteria: * men aged 18 to 70 years * bmi \> 30 * persons who have provided oral consent * persons undergoing surgery for hernia exclusion criteria: * persons without health insurance cover * diabetes * associated diseases: cancer, chronic inflammatory diseases * adults under guardianship diabetic obese subjects inclusion criteria: * men aged 18 to 70 years * type 2 diabetic not treated with insulin or glp-1 agonist * bmi \> 30 * persons who have provided oral consent * persons undergoing surgery for hernia exclusion criteria: * persons without health insurance cover * associated diseases: cancer, chronic inflammatory diseases * adults under guardianship
corticosteroids to treat pancreatitis

Conditions: Pancreatitis; Pancreatitis, Acute; Corticosteroid; Hydrocortisone

Summary: this research is being done to determine if the administration of a short course of intravenous hydrocortisone, an anti-inflammatory medication, to patients with severe acute pancreatitis will improve their clinical outcomes and decrease the length of hospitalization. we think that because inflammation in the body drives the progression of pancreatitis, giving a short course of intravenous hydrocortisone may mitigate disease progression and improve clinical outcomes in patients with severe acute pancreatitis.

this is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous hydrocortisone on clinical outcomes in patients with severe acute pancreatitis. the interventional drug is hydrocortisone (100 mg of hydrocortisone in 50 milliliters of saline solution). the placebo is saline and is identical in appearance and volume to the interventional drug. study drug will be administered intravenously every 8 hours for 72 hours as per standard clinical procedures by nursing staff. the patient's sequential organ failure assessment score (sofa) will be assessed for changes over time. blood will be drawn at several time points to assess biomarkers over time.

Eligibility criteria:
inclusion criteria: 1. adult (≥18 years) 2. acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipase level ≥3x the upper limit of normal. 3. admission or planned admission to an intensive care unit 4. sofa disease severity score ≥3 (or at least 3 points above a known baseline) exclusion criteria: 1. known diagnosis of autoimmune pancreatitis 2. existing clinical indication for corticosteroids at a dose \>5mg of oral prednisone daily (or equivalent) 3. contraindication to receiving corticosteroids 4. protected populations (prisoners) 5. pregnancy

Keywords: bedside index of severity in acute pancreatitis sequential organ failure assessment randomized controlled trial
healthcare costs and resource utilization in aimovig migraine patients: a retrospective study using united states claims data

Conditions: Migraine

Summary: the proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the us from komodo health

the proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the us from komodo health. study data included adjudicated and paid medical and pharmacy claims in the us between november 1, 2017 and september 1, 2019 provided by komodo health.

Eligibility criteria:
inclusion criteria: general cohort * adult (18 years or older) * newly initiating on aimovig (no other claims during a 180-day wash-in period) * had continuous medical and pharmacy benefit eligibility from 180 days pre-index of aimovig through 180-days post-index primary \& secondary objectives sub-cohort - had 3 consecutive months with a claim for aimovig (≤15 days gap between days supply and the subsequent claim to be considered consecutive) primary \& secondary objectives cost sensitivity analyses sub-cohorts * had continuous medical and pharmacy benefit eligibility from 180 days pre-index of aimovig through 270-days post-index to permit assessment of cost outcomes (all-cause and migraine-related) during days 91-270 post-index * had continuous medical and pharmacy benefit eligibility from 180 days pre-index of aimovig to the maximum follow-up time post-index with continuous medical and prescription insurance eligibility until the data end date (september 1, 2019) exclusion criteria: * patients with any claim for another cgrp-targeted medication (ajovy or emgality) during entire study period

Keywords: migraine, erenumab, aimovig
bespoke vs standard instrumentation in tkr

Conditions: Knee Osteoarthritis

Summary: total knee replacement (tkr) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. the pain and function after tkr can be dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated failure. patient specific cutting blocks may result in a more individualised implant placement, improved pain and function following surgery, and a long-lasting implant. this trial is designed to investigate if there is any benefit to bespoke instrumentation in terms of pain and function to the patient, and an economic benefit to the nhs.

total knee replacement (tkr) is an established treatment for 'wear and tear' arthritis and leads to a satisfactory outcome in over 75% of patients. however, this means that up to 25% of patients are not entirely satisfied with their tkr. the longevity and stability of a tkr is greatly dependent on the accuracy of the initial surgery. deviation of more than 3 degrees from the normal axis can lead to abnormal stresses causing the implants to fail. 'patient specific' technology involves preoperative computer assessment of the patients' knee and allows for a 'patient specific' cutting block to be manufactured. this will allow for individual bony cuts specific to the patients own anatomy. 'patient specific' implants and cutting blocks may allow a more optimal implant positioning and are implanted without the need for instrumentation of the femoral medullary canal (thigh), so lower blood loss may result. this could result in improved early range of movement and decreased pain following surgery. the total knee replacement used in this study will be the gmksphere (medacta international) tkr. it has a specific design which more closely resembles a natural unreplaced knee than any other knee replacement. it may help address the phenomenon of 'mid flexion instability', which is where the patient perceives their replaced knee to be unsteady on stairs and slopes. patient specific technology may also result in a cost saving, as it potentially reduces the number of sterilised trays required during the surgery. this study will allow for comparison in knee function and patient outcomes between patients who have undergone their tkr with patient specific cutting blocks compared to conventional cutting blocks. the scans obtained following the surgery could lead to world leading methodology for the assessment of knee replacements and would set a blue print for the evaluation of other knee implants in the future.

Eligibility criteria:
inclusion criteria: * patients with osteoarthritis ('wear and tear') of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon exclusion criteria: * patients with inflammatory arthropathy, patients requiring bone augmentation, ligament incompetence, values deformity \> 5 degrees

Keywords: total knee replacement patient specific instrumentation
risk of bacterial exposure to the anesthesiologist's face during intubation and extubation

Conditions: Anesthesiologists Who Perform Endotracheal Intubation and Extubation

Summary: the practice of intubation and extubation is not without risks to the anesthesiologists. especially, the face of health care worker is the body part most commonly contaminated by splashes and sprays of body fluids. the aim of this study is to determine the incidence of unrecognized exposure to the anesthesiologists' face during endotracheal intubation and extubation. we will perform face shield swab before and after the endotracheal intubation and extubation. all swabs will be cultured for 48 hours and the number of colony forming units before and after the procedures (intubation/extubation) will be compared.


Eligibility criteria:
inclusion criteria: * anesthesiologists who perform endotracheal intubation and extubation for patients scheduled for endotracheal intubation for elective surgeries exclusion criteria: * none
early intervention with a low-intensity leg cycling exercise program for individuals after stroke

Conditions: Stroke

Summary: this is a two-stage study. in the first stage, 30 subjects with stroke (onset \> 2 weeks) are recruited, and they are assessed and recorded with clinical characteristics, sympathetic nerve testing, and twice symptom-limit exercise capacity tests. the second stage would recruited 90 subjects with stroke (onset\>2 weeks), and they are randomized to one of three groups (control, low-intensity, high-intensity). they are evaluated before and after the four-week interval with clinical characteristics and twice symptom-limit exercise capacity tests (baseline and after four-week training) .

this is a two-stage study. in the first stage, 30 subjects with stroke (onset \> 2 weeks) are recruited, and they are assessed and recorded with sympathetic nerve testing, anthropometry, and twice symptom-limit exercise capacity tests.the second stage would recruited 90 subjects with stroke (onset\>2 weeks), and they are randomized to one of three groups. the control group undergoes traditional rehabilitation only, the low-intensity exercise group receives a low-intensity four-week cycle ergometry and traditional rehabilitation. the the high-intensity exercise group gets a high-intensity four-week cycle ergometry and traditional rehabilitation. they are evaluated by sympathetic tests, anthropometry, functional scales and activity questionnaires, and symptom-limit exercise capacity tests before and after the four-week training.

Eligibility criteria:
inclusion criteria: * stroke onset longer than two weeks, * eligible for exercise testing by doctor exclusion criteria: * aphasia, * apraxia

Keywords: stroke exercise capacity
hyperhaes versus placebo - effect on intracranial pressure in sah patients

Conditions: Subarachnoid Hemorrhage

Summary: the purpose of this study is to determine whether 7.2% nacl in 6% hydroxyethyl starch will lower intracranial pressure (icp) in sah-patients with normal or moderately elevated icp in a placebo controlled study, and to describe the haemodynamic effects.

in the acute phase after a sah, many patients need intensive care treatment to control the development of fatally increased intracranial pressure. one type of treatment used is osmotherapy. traditionally mannitol has been the preferred drug, but the use of hypertonic saline solutions has gained more and more acceptance. the immediate effect seems to be equivalent or better than with mannitol, and there seem to be less adverse effects, such as hypovolemia, acute renal failure, hyponatremia, and rebound increase of icp. most clinical studies in patients with life-threatening increase in icp are observational, and show a predictable effect of hypertonic saline. we wanted to strengthen our own findings from such a study by applying the same study model but with a placebo control group in patients with only moderately elevated icp. we also wanted to document the haemodynamic effects, measuring cardiac output, intrathorasic blood volume and extravascular lung water.

Eligibility criteria:
inclusion criteria: * subarachnoid hemorrhage, source of bleeding radiologically or surgically secured * age \> 18 years * mechanically ventilated * sedated * stable hemodynamics * stable intracranial pressure between 10 - 20 mmhg exclusion criteria: - serum sodium \> 160 mmol/l

Keywords: intracranial pressure intracranial hypertension hypertonic solutions saline solutions, hypertonic